Data / Medical devices / Incubator, Neonatal / United States
FDA-registered makers of Incubator, Neonatal in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Incubator, Neonatal (product code FMZ). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Incubator, Neonatal
- Product code
- FMZ
- Country
- United States
Makers of Incubator, Neonatal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | Waukesha, WI, United States | Specification developer | 8 | July 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Datex-Ohmeda, Inc. | Wauwatosa, WI, United States | Specification developer | 7 | October 22, 2025 | 0 | 3 | 2 | api.fda.gov |
| Draeger Medical Systems, Inc. | Telford, PA, United States | Manufacturer | 3 | November 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Tarry Medical Products, Inc. | Danbury, CT, United States | Manufacturer | 1 | May 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.